As one of its final items before leaving for the summer, the Senate overwhelmingly voted to reauthorize the FDA’s user fee agreements through fiscal 2022, completing over two years of work.
The program is expected to bring in $1.42 billion in fees, about a quarter of the agency’s budget, over the next fiscal year — supporting the individual programs that cover reviews of medical devices, drugs, generics, biologics and biosimilars, as well as approximately 5,000 employees — and includes provisions for hiring 230 additional staff over the next five years.
Following the 94-to-1 vote Thursday, the bill now goes to the president’s desk for approval, far ahead of the current MDUFA expiration date of Sept. 30. Sen. Bernie Sanders (I-Vt.) was the sole lawmaker to vote against the bill.
Anticipated medical device fees would increase from $130.2 million to $183.3 million in fiscal 2018, and up to $213.7 million for fiscal 2022, including new fees for de novo reviews. The new fee levels would apply to all applications received after Oct. 1.
The bill passed by the Senate also includes language from several bills introduced over the past year, including one making hearing aids available over the counter. The provision would do away with the need for an examination or signed waiver for a patient to receive the device, and would place them in a new category under Class I devices.
It would also require the FDA to issue regulations for safety and labeling requirements, and to update its draft guidance on personal sound amplification products — consumer electronics that may use similar technology, but are intended for use by individuals with normal hearing ().
Lawmakers ignored President Trump’s calls to have industry fund 100 percent of user fee-related activities. The White House issued an official statement of policy following the House’s passage in mid-July, but Senate leaders said requests to renegotiate the terms of the agreements had come “too late.” — Conor Hale